[go: up one dir, main page]
More Web Proxy on the site http://driver.im/

DK0871476T3 - Dried blood factor preparation containing trehalose - Google Patents

Dried blood factor preparation containing trehalose

Info

Publication number
DK0871476T3
DK0871476T3 DK96900633T DK96900633T DK0871476T3 DK 0871476 T3 DK0871476 T3 DK 0871476T3 DK 96900633 T DK96900633 T DK 96900633T DK 96900633 T DK96900633 T DK 96900633T DK 0871476 T3 DK0871476 T3 DK 0871476T3
Authority
DK
Denmark
Prior art keywords
blood factor
preparation containing
dried blood
containing trehalose
factor preparation
Prior art date
Application number
DK96900633T
Other languages
Danish (da)
Inventor
Bruce Joseph Roser
Original Assignee
Elan Drug Delivery Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Elan Drug Delivery Ltd filed Critical Elan Drug Delivery Ltd
Application granted granted Critical
Publication of DK0871476T3 publication Critical patent/DK0871476T3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Developmental Biology & Embryology (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

A stable blood factor composition contains a stabilising amount of trehalose in the absence of human serum albumin to provide a product stable at up to 60°C.
DK96900633T 1995-01-19 1996-01-19 Dried blood factor preparation containing trehalose DK0871476T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB9501040.1A GB9501040D0 (en) 1995-01-19 1995-01-19 Dried composition
PCT/GB1996/000119 WO1996022107A1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose

Publications (1)

Publication Number Publication Date
DK0871476T3 true DK0871476T3 (en) 2003-11-10

Family

ID=10768253

Family Applications (2)

Application Number Title Priority Date Filing Date
DK96900633T DK0871476T3 (en) 1995-01-19 1996-01-19 Dried blood factor preparation containing trehalose
DK03002147T DK1308170T3 (en) 1995-01-19 1996-01-19 Dried blood factor preparation containing trehalose

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK03002147T DK1308170T3 (en) 1995-01-19 1996-01-19 Dried blood factor preparation containing trehalose

Country Status (15)

Country Link
US (2) US6649386B2 (en)
EP (4) EP0871476B1 (en)
JP (1) JP3898221B2 (en)
KR (1) KR100417593B1 (en)
CN (1) CN1152713C (en)
AT (2) ATE245442T1 (en)
AU (1) AU704317B2 (en)
CA (2) CA2210872C (en)
DE (2) DE69637749D1 (en)
DK (2) DK0871476T3 (en)
ES (2) ES2202425T3 (en)
GB (1) GB9501040D0 (en)
PT (2) PT871476E (en)
SI (1) SI1308170T1 (en)
WO (1) WO1996022107A1 (en)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7244824B2 (en) * 1995-01-19 2007-07-17 Quadrant Drug Delivery Limited Dried blood factor composition comprising trehalose
US6964771B1 (en) 1995-06-07 2005-11-15 Elan Drug Delivery Limited Method for stably incorporating substances within dry, foamed glass matrices
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
GB9616536D0 (en) * 1996-08-06 1996-09-25 Quadrant Holdings Cambridge Co-amoxiclav dosage form
AUPO871997A0 (en) * 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
ES2288843T3 (en) * 1999-02-22 2008-02-01 University Of Connecticut NEW FORMULATIONS OF FACTOR VIII ALBUMIN FREE.
KR101007790B1 (en) * 2001-08-10 2011-01-14 가부시끼가이샤 하야시바라 세이부쓰 가가꾸 겐꾸조 Associates of trehalose or maltitol and metal ion compounds
AU2004274430A1 (en) 2003-09-12 2005-03-31 Antigenics, Inc. Vaccine for treatment and prevention of herpes simplex virus infection
JP5037331B2 (en) * 2004-03-19 2012-09-26 バクスター・インターナショナル・インコーポレイテッド Factor IXA for the treatment of bleeding disorders
EP2168975A3 (en) * 2004-05-24 2012-01-11 Genvault Corporation Method of stably storing biomolecules in recoverable form
KR100624013B1 (en) 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 Pharmaceutical preparation of recombinant factor ? lyophilized without albumin as a stabilizer
US8133484B2 (en) 2006-12-15 2012-03-13 Lifebond Ltd Hemostatic materials and dressing
CA2673260A1 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
EP1958618A1 (en) * 2007-02-15 2008-08-20 Octapharma AG Method for freeze-drying with optimum reconstitution of biopolymers
US20100316625A1 (en) * 2007-12-21 2010-12-16 Inspiration Biopharmaceuticals, Inc. Stabilized factor ix formulations containing trehalose
SG10201608059VA (en) 2007-12-28 2016-11-29 Baxter Int Recombinant vwf formulations
US11197916B2 (en) 2007-12-28 2021-12-14 Takeda Pharmaceutical Company Limited Lyophilized recombinant VWF formulations
WO2010031007A2 (en) 2008-09-12 2010-03-18 Genvault Corporation Matrices and media for storage and stabilization of biomolecules
CA2740919A1 (en) * 2008-10-21 2010-04-29 Baxter International Inc. Lyophilized recombinant vwf formulations
JP5779780B2 (en) 2008-11-07 2015-09-16 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ Factor VIII formulation
US9066991B2 (en) 2009-12-22 2015-06-30 Lifebond Ltd. Modification of enzymatic crosslinkers for controlling properties of crosslinked matrices
WO2013009254A1 (en) * 2011-07-13 2013-01-17 Denator Ab Method for stabilization of fluid biological samples
CN102416171B (en) * 2011-12-06 2013-12-25 中国医学科学院输血研究所 Protective agent in process for performing dry heat virus inactivation on high-purity prothrombin complex concentrate products
US9700486B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
EA030733B1 (en) * 2013-12-19 2018-09-28 Янссен Вэксинс Энд Превеншн Б.В. Liquid composition for preserving virosomes and method of preserving virosomes
CN106687126B (en) 2014-08-04 2020-07-28 杰特有限公司 Factor VIII formulations
MX2017014532A (en) 2015-05-13 2018-02-21 Agenus Inc Vaccines for treatment and prevention of cancer.
CN107333750A (en) * 2017-06-11 2017-11-10 成都吱吖科技有限公司 Blood cell stabilizer when a kind of long
CA3096909A1 (en) 2018-04-26 2019-10-31 Agenus Inc. Heat shock protein-binding peptide compositions and methods of use thereof
US11998654B2 (en) 2018-07-12 2024-06-04 Bard Shannon Limited Securing implants and medical devices
WO2021001522A1 (en) 2019-07-04 2021-01-07 CSL Behring Lengnau AG A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii
US20220380439A1 (en) 2020-11-09 2022-12-01 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption
WO2022261716A1 (en) * 2021-06-16 2022-12-22 Exopharm Limited Aqueous formulations for preservation of extracellular vesicles
WO2024102796A2 (en) * 2022-11-08 2024-05-16 University Of Wyoming Stabilization of biologics and human blood clotting factor viii in a dry state

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4361509A (en) 1981-12-14 1982-11-30 Scripps Clinic And Research Foundation Ultrapurification of factor VIII using monoclonal antibodies
US4495175A (en) * 1982-08-05 1985-01-22 University Of Rochester Preparation of highly purified human antihemophilic factor
WO1987000196A1 (en) * 1985-07-09 1987-01-15 Quadrant Bioresources Limited Protection of proteins and the like
FI86885C (en) 1984-04-20 1992-10-26 Genentech Inc Method for Preparation of Human Recombinant Factor VIII and Nucleic Acid Sequences and Vectors Used thereto
EP0182448A3 (en) 1984-08-24 1987-10-28 Genetics Institute, Inc. Production of factor viii and related products
US4758657A (en) * 1985-07-11 1988-07-19 Armour Pharmaceutical Company Method of purifying Factor VIII:C
US4806343A (en) * 1986-03-13 1989-02-21 University Of Southwestern Louisiana Cryogenic protectant for proteins
CA1329760C (en) 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US4877608A (en) * 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
AU650045B2 (en) * 1990-09-12 1994-06-09 Lifecell Corporation Method and apparatus for cryopreparation dry stabilization and rehydration of biological suspensions
DE4111393A1 (en) 1991-04-09 1992-10-15 Behringwerke Ag STABILIZED FACTOR VIII PREPARATIONS
US5288853A (en) 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
SK282483B6 (en) * 1992-10-02 2002-02-05 Genetics Institute, Inc. Stable composition of coagulating factor viii, its preparation and stabilisation method
SE504074C2 (en) * 1993-07-05 1996-11-04 Pharmacia Ab Protein preparation for subcutaneous, intramuscular or intradermal administration
AU7254894A (en) 1993-07-23 1995-02-20 Baxter International Inc. Activated human factor viii and method of preparation
US5576291A (en) * 1993-09-13 1996-11-19 Baxter International Inc. Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
US5804420A (en) * 1997-04-18 1998-09-08 Bayer Corporation Preparation of recombinant Factor VIII in a protein free medium
ES2288843T3 (en) 1999-02-22 2008-02-01 University Of Connecticut NEW FORMULATIONS OF FACTOR VIII ALBUMIN FREE.

Also Published As

Publication number Publication date
PT1308170E (en) 2008-12-26
CA2671383A1 (en) 1996-07-25
CA2671383C (en) 2012-04-24
EP0871476A1 (en) 1998-10-21
CN1152713C (en) 2004-06-09
US20090149388A1 (en) 2009-06-11
AU4454096A (en) 1996-08-07
CN1179107A (en) 1998-04-15
EP1308170A2 (en) 2003-05-07
EP2258402A3 (en) 2011-01-05
WO1996022107A1 (en) 1996-07-25
KR19980701500A (en) 1998-05-15
DE69637749D1 (en) 2008-12-24
US6649386B2 (en) 2003-11-18
KR100417593B1 (en) 2004-04-30
JP3898221B2 (en) 2007-03-28
EP1974741A1 (en) 2008-10-01
AU704317B2 (en) 1999-04-22
EP1308170A3 (en) 2004-03-03
EP1308170B1 (en) 2008-11-12
ATE245442T1 (en) 2003-08-15
ATE413885T1 (en) 2008-11-15
US7803911B2 (en) 2010-09-28
PT871476E (en) 2003-12-31
SI1308170T1 (en) 2009-04-30
ES2316658T3 (en) 2009-04-16
JPH11503719A (en) 1999-03-30
GB9501040D0 (en) 1995-03-08
DE69629209D1 (en) 2003-08-28
US20020128207A1 (en) 2002-09-12
EP2258402A2 (en) 2010-12-08
CA2210872C (en) 2009-09-08
ES2202425T3 (en) 2004-04-01
CA2210872A1 (en) 1996-07-25
EP0871476B1 (en) 2003-07-23
DK1308170T3 (en) 2008-12-15
DE69629209T2 (en) 2004-02-19

Similar Documents

Publication Publication Date Title
DK0871476T3 (en) Dried blood factor preparation containing trehalose
IT1276723B1 (en) INSULIN ANALOGUE FORMULATIONS
MX9304710A (en) PHARMACEUTICAL AND / OR COSMETIC COMPOSITION AND ITS USE.
NO179911C (en) Optically active 5H-pyrrolo [3,4-bpyrazine derivative as well as pharmaceutical preparations containing the derivative
ES2096727T5 (en) COSMETIC AND PHARMACEUTICAL PRODUCTS CONTAINING EXTENSINES.
DE3675996D1 (en) MEDIUM WITH CONTINUOUS PEPTIDE RELEASE.
ATE129146T1 (en) STICK COMPOSITION CONTAINING SODIUM HYDROCHLORATIC ACID AND STEARYL ALCOHOL.
ATE104554T1 (en) TOPICAL PREPARATIONS.
FI923751A0 (en) HEXAHYDROBENSO / F / KINOLINONER.
ATE132877T1 (en) EMULGATOR-FREE EMULSION POLYMERS IN PHARMACEUTICAL PREPARATIONS WITH DELAYED RELEASE OF ACTIVE INGREDIENTS AND THEIR PRODUCTION
DE68907609D1 (en) MEDICINAL COMPOSITION.
ITMI931371A0 (en) PROCEDURE FOR THE PREPARATION OF ERDOSTEINE
KR900700471A (en) New 2,3-thiomorpholine dione-2-oxime derivatives, pharmaceutical compositions and preparations containing them
KR940021732U (en) Children's shoes
DE3869232D1 (en) BORNAN-3-SPIRO-L'-CYCLOPENTAN COMBATINGS AND THESE FRAGRANT COMPOSITIONS.
KR950026459U (en) Children's backpack with removable shoe bag
KR900016452U (en) Matchbox's red applicator
ES1021366Y (en) CHILDREN'S FOOTWEAR
MX9203261A (en) NEW 12-AMINO-PIRIDAZINO [4 ', 5': 3,4] PIRROLO [2,1-A] -ISOKINOLINS AND PHARMACEUTICAL COMPOSITIONS THAT CONTAIN THEM.
IT1219429B (en) PHARMACEUTICAL COMPOSITIONS WITH ANTIPROLACTIN ACTIVITY
KR910010588U (en) Children's shoes
RO91512A2 (en) DRUG COMPOSITION FOR DERMATOLOGICAL USE
ITAN940061A0 (en) FOOTWEAR WITH LIMITED WEIGHT AND HIGH BREATHABLE CAPACITY
SV1990000045A (en) PREPARATION OF CYCLLOALCAN [B] DEHYDROINDOL E-INOSULFONAMIDES SUBSTITUTED, REF. LE A 27 157-SV.
ES1012015Y (en) PERFECTED CHILDREN'S FOOTWEAR.